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Intra-operative Pancreatoscopy in Patients With IPMN

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ClinicalTrials.gov Identifier: NCT03729453
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

Condition or disease Intervention/treatment
Intraductal Papillary Mucinous Neoplasm Device: SpyGlass

Detailed Description:
The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2027

Group/Cohort Intervention/treatment
Intraoperative Pancreatoscopy
All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.
Device: SpyGlass
Visualization of main pancreatic duct with SpyGlass catheter.




Primary Outcome Measures :
  1. Rate of detection of discontinuous (skip) lesions along the main pancreatic duct [ Time Frame: During index procedure ]
    Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies


Secondary Outcome Measures :
  1. Technical success [ Time Frame: During index procedure ]
    Ability to advance the pancreatoscope along the entire main pancreatic duct length or until clinically needed; to visualize the potential lesion(s); or to obtain a tissue sample with SpyBite where applicable

  2. Adverse Event Evaluation [ Time Frame: Five years ]
    Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device

  3. Recurrence [ Time Frame: Five years ]
    Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method

  4. Comparison of visual and biopsy diagnosis [ Time Frame: During index procedure ]
    Comparison based on exploration with Spy Glass of the resected specimen

  5. Inter-observer correspondence of visual impression of IPMN [ Time Frame: During index procedure ]
    Based on intra-operative impression and on review of recorded pancreatoscopy images/videos



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for surgery for suspected MD-IPMN or Mixed IPMN resection.
Criteria

Inclusion Criteria:

  1. Patient scheduled for surgery for suspected MD-IPMN or Mixed IPMN within 4-6 weeks of enrollment
  2. Diameter of pancreatic main duct >5mm on pre-operative MRI or CT
  3. Written informed consent from patient to participate in the study, including compliance with study procedures

Exclusion Criteria:

  1. Contraindication for pancreatoscopy
  2. Age: less than 18 years
  3. Pregnant women, evaluated per local clinical standard

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729453


Contacts
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Contact: Danielle Vannan 508-683-4139 Danielle.Vannan@bsci.com
Contact: Srey Yin 508-683-4162 Srey.Yin@bsci.com

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: Marco Del Chiaro, MD, PhD         
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christian Schmidt, MD         
United States, Maryland
Johns Hopkins Hospital University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Richard Burkhart, MD         
China
The First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, China, 210029
Contact: Yi Miao, MD, PhD         
India
Asian Institute of Gastroenterology Recruiting
Hyderabad, India, 500-082
Contact: G.V. Rao, MD, PhD         
Japan
Kansai Medical University Not yet recruiting
Hirakata City, Osaka, Japan, 573-1010
Contact: Sohei Satoi, MD, PhD         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Marc Besselink, MD, PhD         
Sweden
University Hospital of UMEA Not yet recruiting
Umea, Sweden, 907 37
Contact: Urban Arnelo, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Marco Del Chiaro, MD University of Colorado, Denver
Principal Investigator: G.V. Rao, MD Asian Institute of Gastroenterology
Principal Investigator: Richard Burkhart, MD Johns Hopkins University
Principal Investigator: Marc Besselink, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Yi Miao, MD Nanjing Medical University
Principal Investigator: Sohei Satoi, MD Kansai Medical University
Principal Investigator: Urban Arnelo, MD University Hospital, Umeå
Principal Investigator: Christian Schmidt, MD Indiana University Health
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03729453    
Other Study ID Numbers: E7107
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boston Scientific Corporation:
IPMN
SpyGlass
Pancreatoscopy
Intraductal Papillary Mucinous Neoplasm
Intraoperative
Surgical
Additional relevant MeSH terms:
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Neoplasms